Inflammatory Markers
Conditions
Keywords
PEC II, PIFB, breast cancer, NLR
Brief summary
The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.
Detailed description
Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis. Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks. Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective. Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks. Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients. The investigators propose to study the impact of novel thoracic wall blocks with dexmetomidine on simple inflammatory markers obtained from full blood count (NLR, PLR, NPR, PDW, MPV, RDW) after breast cancer surgery.
Interventions
PROCEDUREModified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
PECS II: Ultrasound guided block involving injection of 20 ml of 0.25% L-bupivacaine with dexmetomidine into an interfascial plane between the serratus anterior muscle and the external intercostal muscles followed by the needle withdrawal into an interfascial plane between the pectoralis major and pectoralis minor muscle where further 10ml will be administered. PIFB: Ultrasound guided block involving injection of 10 ml of 0.25% L-bupivacaine with dexmetomidine into an iterfascial plane between the pectoralis major and the intercostal muscles approximately 2 cm laterally from the sternum to cover T2 to T6 dermatomes.
Sponsors
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Louis Pasteur University Hospital Kosice
St. Elizabeth Cancer Institute, Slovakia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Intervention will be done under general anesthesia so participant will be blinded and primary outcome which will be laboratory test will be assessed by a person not aware of intervention.
Intervention model description
120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy. * Older than 18 years * ASA I-III
Exclusion criteria
* Weight \< 50 kg * BMI \> 35 * Allergy to local anaesthetic or dexmetomidine * Contraindications to NSAIDs use * Local infection over block site * Coagulopathy * Preexisting chronic pain * Pregnancy * Autoimmune disease * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in NLR | 24 hours after surgery | Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Markers of inflammation | 24 hours after surgery | Difference in Δ NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery |
| Intraoperative opioids | Duration of surgery | Intraoperative consumption of opioids |
| Pain after surgery | 1,6,12,18,24 hours after surgery | Numeric rating scale for pain (NRS, 0-10, where 0 means no pain and 10 the worst pain) at 0, 1h, 6h, 12h,18h,24h after surgery at rest and at ipsilateral arm abduction |
| Opioid consumption | 24 hours | Total opioid consumption after surgery at 24 h |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 24 hours | Incidence of potential adverse effects |
| Postsurgical pain | 3 months after surgery | Incidence of postsurgical pain at 1month, 2month and 3 months |
Contacts
Primary ContactTomas Hitka, MD
Backup ContactRoman Zahorec, MD
Outcome results
None listed